Efficacy and safety of aerosol inhalation of recombinant human interferon-α2b injection in children hospitalized with human adenovirus pneumonia: a prospective, multicenter, randomized, controlled trial in China
Abstract
Background: Human adenovirus (HAdV) pneumonia represents one of the gravest threats to child health worldwide. However, effectively and safely antiviral strategies for HAdV infections remain limited. In this study, we aimed to comprehensively investigate the efficacy and safety of aerosol inhalation of recombinant human interferon-α2b (IFN-α2b) injection in children hospitalized with HAdV pneumonia. Methods: This randomized controlled trial recruited children aged ≤5 years hospitalized for HAdV pneumonia from nine hospitals in China. Subjects were randomized 1:1 to receive either aerosol inhalation of IFN-α2b (200 000 IU/kg) plus routine supportive treatment or aerosolized normal saline plus supportive therapy, with a 7-day treatment period. Primary outcome indexes were viral DNA negative conversion rate and overall effective rate, while the secondary indexes included disappearance time of various symptoms, overall symptom improvement rate (OSIR), and levels of inflammatory indicators (TNF-α, IL-6, CRP, and LDH). Noteworthily, besides common clinical and laboratory indexes, two crucial effector proteins [2′,5′-oligoadenylate synthetase (OAS), β2 microglobulin (β2M)] of IFN-mediated antiviral responses were assayed using the ELISA method. Additionally, safety assessment parameters consisted of vital signs, biochemical indicators of liver and kidney function (ALT, AST, urea, creatinine), and incidence of adverse events. Results: A total of 140 eligible subjects were enrolled,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 140 participants or records.
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